Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: A randomized controlled trial

Abstract

Objectives: To assess the efficacy and safety of NSF-3, a polyherbal sedative-hypnotic (containing standardized extracts of Valeriana officinalis, Passiflora incarnate and Humulus lupulus), in comparison to zolpidem in primary insomnia. Materials and Methods: The present study was designed as a parallel group, double- blind, randomized, controlled trial and registered with Clinical Trials Registry-India (CTRI/2011/12/002197). Patients diagnosed with primary insomnia with a perceived total sleep time of <6 hours per night and insomnia severity index >7 were included. They were treated with either NSF-3 (one tablet) or zolpidem (one 10 mg tablet) at bedtime for two weeks. Total sleep time, sleep latency and number of awakenings per night were assessed using a sleep diary. Quality of life and daytime sleepiness were evaluated by insomnia severity index and Epworth sleepiness score respectively. Vital signs, routine blood counts, liver and renal function tests, and treatment emergent adverse events were recorded for safety assessment. Results: A total of 91 subjects were recruited, of which 39 in each group completed the study. There was significant improvement in total sleep time, sleep latency, number of nightly awakenings and insomnia severity index scores in both groups. However, no statistically significant difference was observed between the groups. Epworth sleepiness scores did not change significantly over the study period. Although 12 treatment emergent adverse events were reported with NSF-3 and 16 with zolpidem (commonest was drowsiness in both), most were mild and no serious adverse events were encountered. Conclusions: NSF-3 is a safe and effective short-term alternative to zolpidem for primary insomnia. It remains to be explored whether the benefits are sustained and whether there is dependence liability with this formulation upon long term use. [PUBLICATION ABSTRACT]